HysterectomyPhase 2/3NCT03363425
Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery
A Phase 2/3 study testing Lidocaine Iv, Dexmedetomidine and Normal saline in people with Hysterectomy and Myomectomy, run by University of Athens at 1 site in Greece.
Trial summary
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Myomectomy
- What is being tested?
- Lidocaine Iv, Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 14 Nov 2017to Nov 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women
- ASA I-II
- 30-70 years
- abdominal gynaecological surgery
Who cannot join
- patient's refusal
- contraindication to the use of local anesthetics
- body mass index >30 kg/m2
- history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- pregnant women
- significant renal or hepatic impairment
Show all 12Show fewer
- insulin-dependent diabetes mellitus
- central nervous system disease or psychiatric diseases
- chronic use of opioids, steroids, clonidine (or other a2 agonist)
- use of drugs acting on the central nervous system or analgesics during the previous 2 weeks
- drug/alcohol abuse
- inability to comprehend the following pain assessment scale
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieio University Hospital
Athens
Martina Rekatsina, 00306975104139, mrekatsina@gmail.com
About this study
Official title: Effect of Perioperative Intravenous Infusion of Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption, Bowel Function and Recovery After Abdominal Gynaecological Surgery: a Randomised Double Blind Study
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.
- Conditions
- Hysterectomy, Myomectomy
- Being tested
- Lidocaine Iv, Dexmedetomidine, Normal saline
- Keywords
- Dexmedetomidine, Lidocaine, Postoperative Pain, Analgesic Consumption, Recovery, Abdominal Gynaecological Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IvDrug
Lidocaine Iv
DexmedetomidineDrug
dexmedetomidine iv
Normal salineDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Not described Receives: Drug: Lidocaine Iv |
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Normal Saline 0,9% | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic consumption 24 hours postop
morphine consumption from PCA
Measured: 24 hours postoperatively
Secondary outcomes (6)
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Measured: 0 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Measured: 2 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Measured: 4 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Measured: 8 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Measured: 24 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start14 Nov 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staikou Chryssoula, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363425
- Sponsor's protocol ID
- EE-2/04/31-01-2017
- Status last verified
- Dec 2017
- First submitted
- 23 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rekatsina M, Theodosopoulou P, Staikou C. Perioperative Dexmedetomidine or Lidocaine Infusion for the Prevention of Chronic Postoperative and Neuropathic Pain After Gynecological Surgery: A Randomized, Placebo-Controlled, Double-Blind Study. Pain Ther. 2022 Jun;11(2):529-543. doi: 10.1007/s40122-022-00361-5. Epub 2022 Feb 15.
PubMed 35167059Rekatsina M, Theodosopoulou P, Staikou C. Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study. Pain Physician. 2021 Nov;24(7):E997-E1006.
PubMed 34704710
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Intravenous Infusion of Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption, Bowel Function and Recovery After Abdominal Gynaecological Surgery: a Randomised Double Blind Study
- ClinicalTrials.gov ID
- NCT03363425
- Acronym / sponsor ID
- EE-2/04/31-01-2017
- Conditions
- Hysterectomy, Myomectomy
- Keywords
- Dexmedetomidine, Lidocaine, Postoperative Pain, Analgesic Consumption, Recovery, Abdominal Gynaecological Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine Iv |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| Normal Saline 0,9% | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women
- ASA I-II
- 30-70 years
- abdominal gynaecological surgery
Key exclusion criteria (12 listed)
- patient's refusal
- contraindication to the use of local anesthetics
- body mass index >30 kg/m2
- history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine IvLidocaine Iv | Drug | Lidocaine |
| Dexmedetomidinedexmedetomidine iv | Drug | Dexmedetomidine |
| Normal salineplacebo | Drug | Normal Saline 0,9% |
Primary outcome
analgesic consumption 24 hours postop
Time frame: 24 hours postoperatively
morphine consumption from PCA
6 secondary outcomes
postoperative pain
Time frame: 0 hours postoperatively
postoperative pain
Time frame: 2 hours postoperatively
postoperative pain
Time frame: 4 hours postoperatively
postoperative pain
Time frame: 8 hours postoperatively
postoperative pain
Time frame: 24 hours postoperatively
postoperative pain
Time frame: 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Derived from this study: PubMed 35167059Rekatsina M, Theodosopoulou P, Staikou C. Perioperative Dexmedetomidine or Lidocaine Infusion for the Prevention of Chronic Postoperative and Neuropathic Pain After Gynecological Surgery: A Randomized, Placebo-Controlled, Double-Blind Study. Pain Ther. 2022 Jun;11(2):529-543. doi: 10.1007/s40122-022-00361-5. Epub 2022 Feb 15.
- Derived from this study: PubMed 34704710Rekatsina M, Theodosopoulou P, Staikou C. Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study. Pain Physician. 2021 Nov;24(7):E997-E1006.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine Iv, Dexmedetomidine and Normal saline in people with Hysterectomy and Myomectomy, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic consumption 24 hours postop (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.